Female Stress Urinary IncontinenceNCT01699425
Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
A study testing Ajust sling and Classical transobturator sling in people with Female Stress Urinary Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 5 sites in Spain.
Trial summary
The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- Ajust sling and Classical transobturator sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesSpain
- Study dates
- Mar 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence with urethral hypermobility.
Who cannot join
- Incapacity to understand the information or give their consent.
- Previous anti-incontinence surgery with slings.
- Urethral hypomobility (Q-tip test <30º).
- Low pressure urethra (MUCP < 20cmH2O).
- Detrusor overactivity.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, E-08035
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Girona
Hospital Universitari de Bellvitge
Hospitalet, Barcelona
Hospital de Palamós
Palamós, Girona
Hospital de Viladecans
Viladecans, Barcelona
About this study
The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In addition it is commonly performed under general or regional anesthesia1-3. The single-incision mini-slings (SIMS) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. In addition, the use of SIMS could enable surgeons to perform the procedure truly under local anesthesia.
Different devices for SIMS procedure are available. However, the evidence about their efficacy is controversial4-7. The main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. Recent prospective studies on the efficacy and safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use SIMS in the context of research studies10.
The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- Ajust sling, Classical transobturator sling
- Keywords
- Stress urinary incontinence., Suburethral sling., Single-incision suburethral sling., Ajust., Transobturator tape.
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ajust slingDevice
Classical transobturator slingDevice
Also called Align®
Control group
| Study group | Role | What they receive |
|---|---|---|
| Ajust | Experimental | Experimental group: surgery to treat stress urinary incontinence with the sling Ajust® Receives: Device: Ajust sling |
| Classical transobturator tape | Active comparator | Control group: surgery to treat stress urinary incontinence with the Align® sling. Receives: Device: Classical transobturator sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes.
Percentage of patients who are regarded as cured or improved based on the following criteria:
- Improvement on the International consultation on Incontinence Urinary Questionnaire-Short Form 1 year after the surgery.
- Negative Cough Stress test 1 year after surgery.
Measured: Up to one year
Secondary outcomes (1)
Number of participants with adverse events
Comparison of the intra- and postoperative complications between procedures
Measured: 0, 1, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital de Viladecans, Serveis de Salut Integrats Baix Empordà
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699425
- Sponsor's protocol ID
- AJA201205
- Status last verified
- Mar 2017
- First submitted
- 22 Sep 2012
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
- ClinicalTrials.gov ID
- NCT01699425
- Acronym / sponsor ID
- AJA201205
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence., Suburethral sling., Single-incision suburethral sling., Ajust., Transobturator tape.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital de Viladecans, Serveis de Salut Integrats Baix Empordà
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In addition it is commonly performed under general or regional anesthesia1-3. The single-incision mini-slings (SIMS) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. In addition, the use of SIMS could enable surgeons to perform the procedure truly under local anesthesia.
Different devices for SIMS procedure are available. However, the evidence about their efficacy is controversial4-7. The main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. Recent prospective studies on the efficacy and safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use SIMS in the context of research studies10.
The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ajust | Experimental | Device: Ajust slingExperimental group: surgery to treat stress urinary incontinence with the sling Ajust® |
| Classical transobturator tape | Active comparator | Device: Classical transobturator slingControl group: surgery to treat stress urinary incontinence with the Align® sling. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stress urinary incontinence with urethral hypermobility.
Key exclusion criteria (5 listed)
- Incapacity to understand the information or give their consent.
- Previous anti-incontinence surgery with slings.
- Urethral hypomobility (Q-tip test <30º).
- Low pressure urethra (MUCP < 20cmH2O).
- Detrusor overactivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ajust sling | Device | Ajust |
| Classical transobturator slingAlso: Align®Control group | Device | Classical transobturator tape |
Primary outcome
Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes.
Time frame: Up to one year
Percentage of patients who are regarded as cured or improved based on the following criteria: * Improvement on the International consultation on Incontinence Urinary Questionnaire-Short Form 1 year after the surgery. * Negative Cough Stress test 1 year after surgery.
1 secondary outcome
Number of participants with adverse events
Time frame: 0, 1, 6 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ajust sling and Classical transobturator sling in people with Female Stress Urinary Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.